Study Design and Study Population
FIDEL (FIbrinogen in DELivery) is a randomized, multicentre, double-blind, placebo-controlled study on the efficacy and safety of a therapeutic strategy comparing early and systematic administration of human fibrinogen versus placebo in patients with PPH when switched from intravenous oxytocin to prostaglandins following vaginal delivery. The full study protocol is available in Supplement 1. The initial protocol was published in 2016 19. The study was sponsored and funded by the company LFB (Les Ulis, France), which holds the marketing authorization for Clottafact® (fibrinogen concentrate). The double-blind versus placebo research, data collection and results interpretation were conducted by an independent organism (Euraxi France) under the closed oversight of the scientific committee and the independent monitoring committee.
The FIDEL study was conducted in 30 public or private tertiary care hospitals in France. Subjects meeting the following main inclusion criteria (age ≥ 18 years, with PPH following vaginal delivery requiring continuous intravenous prostaglandin administration (sulprostone, at an initial rate of 500 µg/h, according to guidelines 16), with at least one haemoglobin (Hb) value available for the third trimester of pregnancy) were included and randomized. The other inclusion and non-inclusion criteria were described previously19. Given the emergency context, consent was obtained after brief delivery of information to the patient, or a relative or reliable person, depending on the patient’s level of consciousness. In all cases, as soon as possible, the patient was fully informed about the study and asked to sign a post-inclusion consent form to continue participating.
Funding :
The study was sponsored and funded by the company LFB (Les Ulis, France), which holds the marketing authorization for Clottafact® (fibrinogen concentrate). The study was concepted and performed according to a double blind versus placebo design. Conception conduct of the study, quality assessment, data-management, blinded data validation, statistical management quality and paper writing were conducted under the oversight of the scientific committee. The awarded grant included external peer review for data collection,applicable regulation and scientific quality.